Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080409
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LTA II KIT | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/06/1972 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/04/1992 | SUPPL-28 | Labeling |
Label is not available on this site. |
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06/13/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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07/25/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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08/09/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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07/19/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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06/04/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/04/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |